(30 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .
The intended for use of this over-the-counter device is for age 16 and above.
Full Automatic (NIBP) Blood Pressure Monitor
I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding acceptance criteria, study details, and ground truth establishment for the HL168D Non-Invasive Blood Pressure Monitor. The document is a 510(k) clearance letter from the FDA, which confirms substantial equivalence but does not describe the specific performance studies in detail.
The letter mentions that the device "Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method." It also states "The intended for use of this over-the-counter device is for age 16 and above." However, it does not provide quantitative acceptance criteria for blood pressure and heart rate measurements, nor does it present the results of specific studies against such criteria.
Therefore, I cannot provide the requested table and detailed responses based on the input document.
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Public Health Service
AUG 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan Chen Health & Life Co., Ltd. 6F, No. 407, Chung Shan Road, Sec. 2 Chung Ho City Taipei Hsien TAIWAN R.O.C.
Re: K012310
Trade Name: HL168D Non-Invasive Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulatory Class: Class II (two) Product Code: 74 DXN Dated: June 29, 2001 Received: July 23, 2001
Dear Ms. Chen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce suice in also 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetic Pro (110) - The general controls provisions of the Act include requirements for annual provisions of atives of atives, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Frediation I ipproval), while Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mopolwaiith the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might
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Page 2 - Ms. Susan Chen
have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
nes E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO12310 510(k) Number (if known) :
Device Name : Full Automatic (NIBP) Blood Pressure Monitor
Trade Name : HL168D
Indications For Use
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .
The intended for use of this over-the-counter device is for age 16 and above.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription USE ( ) (Per 21 CFR 801.109) OR
Over-The-Counter Use( √ ) ( Optional Format 1-2)
K012310
Division of Cardiovascular & Respiratory Devices
510(k) Number
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).